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Revised SOPs for Aerosols V 2.0

Aerosol: SOP for Charging Propellants in Aerosol Manufacturing – V 2.0

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This Standard Operating Procedure (SOP) outlines the process for charging propellants into aerosol cans during manufacturing. The purpose of this procedure is to ensure that the propellant is added in a controlled, safe, and precise manner, maintaining the integrity of the formulation and ensuring product performance and safety. The SOP covers the required steps for propellant charging, equipment preparation, safety protocols, and documentation.
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Aerosols V 2.0

Aerosol: SOP for Homogenization of Formulations in Aerosol Manufacturing – V 2.0

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This Standard Operating Procedure (SOP) outlines the process for homogenizing formulations during aerosol manufacturing. The purpose is to ensure that the formulation is uniform, with all ingredients evenly dispersed throughout the mixture. Homogenization is crucial for ensuring consistent product quality, performance, and stability. This procedure provides guidance on equipment, techniques, and documentation required during the homogenization process.
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Aerosols V 2.0

Aerosol: SOP for Filling Liquid Components into Aerosol Containers – V 2.0

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This Standard Operating Procedure (SOP) outlines the process for filling liquid components into aerosol containers during manufacturing. The objective of this SOP is to ensure that the liquid formulation is accurately and consistently filled into aerosol containers, while minimizing the risk of contamination or overfilling, ensuring product quality, and maintaining compliance with GMP standards.
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Aerosols V 2.0

Aerosol: SOP for Valve Crimping During Aerosol Manufacturing – V 2.0

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This Standard Operating Procedure (SOP) outlines the process for valve crimping during aerosol manufacturing. The purpose of this SOP is to ensure that the aerosol containers are sealed properly with the valve system, preventing leakage, ensuring product integrity, and maintaining compliance with GMP standards. Proper crimping ensures that the propellant is securely contained within the can and that the formulation is safely dispensed when the actuator is engaged.
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Aerosols V 2.0

Aerosol: SOP for Gas Filling in Aerosol Cans – V 2.0

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This Standard Operating Procedure (SOP) outlines the process for filling aerosol cans with gas (propellant) during manufacturing. The purpose is to ensure that the correct amount of gas is filled into each can under controlled conditions, preventing overfilling or underfilling, maintaining product integrity, and ensuring product safety and performance. This procedure also includes ensuring that the canisters are sealed properly to contain the propellant securely.
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Aerosols V 2.0

Aerosol: SOP for Quality Check During Propellant Filling – V 2.0

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This Standard Operating Procedure (SOP) defines the process for conducting quality checks during the propellant filling stage of aerosol manufacturing. The objective is to ensure that the correct amount of propellant is accurately filled into each can while maintaining product quality, consistency, and safety. This procedure ensures that the gas filling process is monitored, deviations are detected, and corrective actions are implemented as necessary to comply with GMP standards.
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Aerosols V 2.0

Aerosol: SOP for Continuous Agitation of Suspension Formulations – V 2.0

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This Standard Operating Procedure (SOP) outlines the process for maintaining continuous agitation of suspension formulations during aerosol manufacturing. The objective of this SOP is to ensure that the suspension is uniformly mixed and that the active ingredients are evenly distributed throughout the formulation, which is critical for the consistency, stability, and performance of the final product.
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Aerosols V 2.0

Aerosol: SOP for Operating Manufacturing Equipment in Clean Rooms – V 2.0

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This Standard Operating Procedure (SOP) outlines the process for operating manufacturing equipment in clean room environments during aerosol production. The purpose of this SOP is to ensure that all equipment is operated under controlled conditions to prevent contamination, ensure the safety of the product, and maintain compliance with GMP standards.
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Aerosols V 2.0

Aerosol: SOP for Maintaining Manufacturing Process Parameters – V 2.0

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This Standard Operating Procedure (SOP) outlines the process for maintaining and controlling manufacturing process parameters during aerosol production. The purpose of this SOP is to ensure that all manufacturing parameters such as temperature, pressure, speed, and mixing time are consistently maintained to meet the required specifications for product quality, safety, and performance. By maintaining strict control over process parameters, we ensure compliance with GMP standards and minimize variability in the final product.
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Aerosols V 2.0

Aerosol: SOP for Handling Overfills and Underfills During Aerosol Filling – V 2.0

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This Standard Operating Procedure (SOP) defines the process for handling overfills and underfills that may occur during the aerosol filling process. The objective is to ensure that the correct volume of product is dispensed into each aerosol can, maintaining consistency and quality of the final product while minimizing waste or inefficiencies. This SOP also ensures that any overfill or underfill deviations are identified, documented, and corrected promptly.
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Aerosols V 2.0

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Standard Operating Procedures V 1.0

  • Aerosols
  • Analytical Method Development
  • Bioequivalence Bioavailability Study
  • Capsule Formulation
  • Clinical Studies
  • Creams
  • Data Integrity
  • Dental Dosage Forms
  • Drug Discovery
  • Environment, Health and Safety
  • Formulation Development
  • Gels
  • Good Distribution Practice
  • Good Warehousing Practices
  • In-Process Control
  • Injectables
  • Liquid Orals
  • Liposome and Emulsion Formulations
  • Lotions
  • Lyophilized Products
  • Maintenance Dept.
  • Medical Devices
  • Metered-Dose Inhaler
  • Microbiology Testing
  • Nanoparticle Formulation
  • Nasal Spray Formulations
  • Nebulizers
  • Ocular (Eye) Dosage Forms
  • Ointments
  • Otic (Ear) Dosage Forms
  • Pharmacovigilance
  • Powder & Granules
  • Purchase Departments
  • Quality Assurance
  • Quality Control
  • Raw Material Stores
  • Regulatory Affairs
  • Tablet Manufacturing
  • Rectal Dosage Forms
  • Transdermal Patches
  • Vaginal Dosage Forms
  • Validations and Qualifications

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NEW! Revised SOPs – V 2.0

  • Aerosols V 2.0
  • Analytical Method Development V 2.0
  • API Manufacturing V 2.0
  • BA-BE Studies V 2.0
  • Biosimilars V 2.0
  • Capsules V 2.0
  • Creams V 2.0
  • Elixers V 2.0
  • Ointments V 2.0
  • Raw Material Warehouse V 2.0
  • Tablet Manufacturing V2.0

New Publication: A must for All.

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